NCT06075810

A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: MBQ Pharma · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.

Detailed description

The main questions this clinical trial aims to answer are: * What, if any, are the side effects of different dose levels in humans? * What is the maximum tolerated dose? * How does the human body process the drug? * Does the drug slow, stop or eliminate cancer in human participants? Participants will be asked to: * provide informed consent * be evaluated by physicians and provide laboratory specimens to determine if eligible * take MBQ-167 orally twice a day for at least 21 days * may continue dosing, if safe to do so, until not effective or other decision to stop is made * participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug

Conditions

• Breast Cancer
• Breast Neoplasm
• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	MBQ-167	MBQ-167, an inhibitor of Rho GTPases Rac and Cdc42

Timeline

• Start date: 2023-11-09
• Primary completion: 2025-10-01
• Completion: 2025-10-31
• First posted: 2023-10-10
• Last updated: 2024-12-12

Locations

4 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study